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OpenTrials
Completed

NCT Number: NCT03329443

The Effect of Spironolactone on Acute Kidney Injury in Patients Undergoing Coronary Angiography

an interventional study to measure the possible effects of spironolactone ( an aldosterone antagonist) on the incidence of acute kidney injury after coronary angiography

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Al-Sader Teaching Hospital

Basra, 00964, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients admitted to angiography unit
  • over 18
  • informed consent

Exclusion criteria

  • acute renal failure before 7 days
  • spironolactone contraindications
  • hyperkalemia (S.K. >5.5 mEq/L)
  • documented tumor
  • actively taking NSAIDs, Ciclosporin, Cisplatin,

Treatment and study plan

Spironolactone

Drug

each patient will receive 200 mg of spironolactone as per his/her angiography premedications

Other names: Active group

Placebo oral tablet

Drug

Each patient will receive a placebo tablet as per his/her angiography premedications

Other names: Control group

Primary outcomes

  1. Acute kidney injury by K-DIGO guidelines

    Time frame: 48-72 hrs

    an absolute elevation of serum creatinine of 0.5mg/dl or 25% above baseline

Secondary outcomes

  1. acute kidney injury by NGAL

    Time frame: 6 hours

    assessment of serum NGAL at admission and after 6 hrs to detect possible AKI in selected patients

Other outcomes

  1. safety outcome: serum potassium

    Time frame: 6 hrs

    serum potassium after 6 hrs of angio

Sponsors and collaborators

Lead sponsor

Alhasan Mujtaba Abdul-Wahid

Other

Collaborators

  • Ministry of Health-Basra Health Directorate-Al-Sader Teaching Hospital

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 6, 2017
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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